Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
Phenobarbital
Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage
17 other identifiers
interventional
610
1 country
11
Brief Summary
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 1993
Typical duration for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 1997
CompletedFirst Submitted
Initial submission to the registry
February 1, 2001
CompletedFirst Posted
Study publicly available on registry
February 5, 2001
CompletedMarch 22, 2019
March 1, 2019
2 years
February 1, 2001
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neonatal intracranial hemorrhage or death
72 hours of life
Secondary Outcomes (3)
Intracranial hemorrhage (grade I, II, III, or IV)
72 hours of life
Periventricular leukomalacia
72 hours of life
Neurodevelopmental impairment
18 to 22 months of corrected age
Study Arms (2)
Phenobarbital
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)
Eligibility Criteria
You may qualify if:
- Admission to a high risk perinatal unit or labor and delivery unit;
- to 32 completed weeks gestation;
- Expected delivery within 24 hrs;
- Preterm labor or no labor with planned delivery for maternal-fetal indications;
You may not qualify if:
- Anticipated delivery within two hours
- Multiple congenital or chromosomal abnormalities in the fetus
- Multiple gestation with more than two fetuses
- Administration of phenobarbital during the pregnancy
- Administration of indomethacin within one week before admission
- Maternal platelet count of less than 100,000 per cubic millimeter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Related Publications (3)
Shankaran S, Papile LA, Wright LL, Ehrenkranz RA, Mele L, Lemons JA, Korones SB, Stevenson DK, Donovan EF, Stoll BJ, Fanaroff AA, Oh W. The effect of antenatal phenobarbital therapy on neonatal intracranial hemorrhage in preterm infants. N Engl J Med. 1997 Aug 14;337(7):466-71. doi: 10.1056/NEJM199708143370705.
PMID: 9250849RESULTMcCain GC, Donovan EF, Gartside P. Preterm infant behavioral and heart rate responses to antenatal phenobarbital. Res Nurs Health. 1999 Dec;22(6):461-70. doi: 10.1002/(sici)1098-240x(199912)22:63.0.co;2-t.
PMID: 10625862RESULTShankaran S, Papile LA, Wright LL, Ehrenkranz RA, Mele L, Lemons JA, Korones SB, Stevenson DK, Donovan EF, Stoll BJ, Fanaroff AA, Oh W, Verter J. Neurodevelopmental outcome of premature infants after antenatal phenobarbital exposure. Am J Obstet Gynecol. 2002 Jul;187(1):171-7. doi: 10.1067/mob.2002.122445.
PMID: 12114906RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Seetha Shankaran, MD
Wayne State University
- PRINCIPAL INVESTIGATOR
Lu-Ann Papile, MD
University of New Mexico
- PRINCIPAL INVESTIGATOR
Richard A. Ehrenkranz, MD
Yale University
- PRINCIPAL INVESTIGATOR
Raymond Bain, PhD
George Washington University
- PRINCIPAL INVESTIGATOR
James A. Lemons, MD
Indiana University
- PRINCIPAL INVESTIGATOR
Sheldon B. Korones, MD
University of Tennessee at Memphis
- PRINCIPAL INVESTIGATOR
David K. Stevenson, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Edward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Barbara J. Stoll, MD
Emory University
- PRINCIPAL INVESTIGATOR
Avroy A. Fanaroff, MD
Case Western Reserve University
- PRINCIPAL INVESTIGATOR
William Oh, MD
Brown University, Women and Infants Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
February 1, 2001
First Posted
February 5, 2001
Study Start
February 1, 1993
Primary Completion
February 1, 1995
Study Completion
February 1, 1997
Last Updated
March 22, 2019
Record last verified: 2019-03